Balancing cost, effectiveness and risk of treatment: the FASTT results.
Engaging in well designed and executed research in the world of fertility treatment
Now we have insight into comparing cost effectiveness of low-tech options (Clomid or gonadotropin therapy) versus IVF treatment (3). The FASTT study started in September 2001 with 503 women between the ages of 21-39, the average age was 33, and continued until April 2006. A few months ago the final results were published, after a nine-year process. The study took place at Boston IVF Center in Massachusetts, a state where fertility treatment is a covered health insurance benefit, including up to six IVF cycles. After a full fertility evaluation confirmed that the couples had Unexplained Infertility, the patients were enrolled in the study. Patients were randomly assigned to one of two treatment plans: 1) Three cycles of Clomid plus intrauterine insemination (IUI), followed by 3 cycles of gonadotropin/IUI, then up to 6 IVF embryo transfer cycles (Conventional treatment), or 2) Three cycles of Clomid/IUI followed by up to 6 IVF embryo transfer cycles (Accelerated treatment). All treatment protocols, medication dosing, and number of embryos transferred were practiced similarly among the patients. In addition, the patients kept a diary of additional time and money spent in each treatment cycle. This cost included time away from work, medication co-pays, and payment for additional care (e.g. emotional counseling).
A financial analysis of the total charges incurred for each patient from the time of entry into the study until the patient had a delivery (including pregnancy and newborn care); the patient stopped treatment; or the study was closed. The study’s two primary endpoints were comparing: 1) time to pregnancy, and 2) health care costs associated with that pregnancy/delivery. Secondary endpoints were per-cycle pregnancy rates, per-couple pregnancy rates, and adverse outcomes. Sixty-four percent of couples delivered at least one live-born baby by the close of the study in 2006 (150 conventional and 171 accelerated). The time-to-pregnancy was statistically shorter for the accelerated group compared to the conventional group. The estimated time-to-pregnancy was 8 months in the accelerated arm and 11 months in the conventional arm. This 3-month difference between the two groups would suggest that the additional 3 months doing gonadotropin/IUI cycles did not contribute to a shorter time-to-pregnancy than the 3 Clomid/IUI cycles alone. Per-cycle pregnancy rates for Clomid/IUI, gonadotropin/IUI and IVF were 7.6%, 9.8% and 30% respectively. The very slight increase seen in the gonadotropin/IUI rates did not have any impact on the “time-to-pregnancy rates” (as noted above), and yet are much more costly cycles than a Clomid/IUI cycle (average $500/cycle vs. $2500/cycle). In the Guzick study, the greatest number of High Order Multiple (HOM) pregnancies (triplets or greater) was in the gonadotropin/IUI cycles. This finding has been echoed by a number of other studies.
In the FASTT report, there were an equal number of HOM pregnancies in each group. In the conventional group, there were two sets of triplets, both from gonadotropin cycles. In the accelerated group, there were 3 sets of triplets, one from Clomid, and two from IVF. The average number of embryos transferred in the IVF group was 2.3. With the improvement in IVF laboratory techniques, many IVF centers currently advocate for transfers of only one embryo in women with an average age of 33. This practice trend will likely decrease the number of HOM in IVF, and would most likely present further benefit (safety and financial) to the accelerated strategy. A cost effective analysis shows the total charges per delivery to be $9,846 lower for the accelerated group ($61,553 per delivery) than the conventional group ($71,399 per delivery). If the analysis is limited to charges of infertility treatment per delivery, the difference was $5,802 in favor of the accelerated arm. The observed incremental difference in charges per couple was a savings of $2,624 for the accelerated treatment, and an increase in the proportion of couples with deliveries of 0.06.
In the parlance of cost-effectiveness analysis, accelerated treatment dominates conventional treatment. This analysis holds true as long as the charges of an IVF cycle are <$17,749 (which, even in today’s dollar, is a realistic expectation for patients in their early 30s). In summary, for patients with Unexplained Infertility, doing 3 cycles of gonadotropin/IUI after 3 cycles of Clomid/IUI was of no added benefit. Accelerated treatment to IVF saves money and results in a greater proportion of couples with delivery of a live-born baby. In terms of the financial benefit, the charges for treatment, pregnancy and delivery were less for couples in the accelerated arm compared to the conventional arm. Pacific Fertility Center strives to provide patients with treatment recommendations and protocols based on sound science. We appreciate and are thankful to our IVF colleagues who have the tenacity and ability to proceed with studies such as this FASTT study. We all benefit from their efforts! Isabelle Ryan, MD (1) Guzick et al. Efficacy of superovulation and intrauterine insemination in the treatment of infertility, N Engl J Med 1999;340:177-83 (2) Ryan, I; A Most Frustrating Diagnosis; June 2009, Fertility Flash Science Pulse, Vol 7, issue 4; http://www.pacificfertilitycenter.com/fertilityflash/vol7_issue4.htm#Article1 (3) Reindollar et al. A randomized clinical trial to evaluate optimal treatment for unexplained infertility: the fast track and standard treatment (FASTT) trial, Fert Ster 2010; 94:3,888-898